Methods for treating vasomotor symptoms using GABA analogs in a gastric retentive dosage form

Abstract

Methods for treating vasomotor symptoms associated with menopause are described.

1. A method for improving quality of sleep at night in a subject experiencing vasomotor symptoms, comprising:
 administering to a subject experiencing vasomotor symptoms a twice-daily dose of gabapentin in a dosage form comprising a hydrophilic polymer, wherein after administration the dosage form swells to a size that is retained in the stomach of the subject in a fed mode, and wherein the administering comprises administering a first dose of 600 mg with a morning meal and a second dose of 1200 mg with an evening meal; 
 whereby the dose of gabapentin improves the quality of sleep at night in the subject, as measured by the Pittsburgh Quality Sleep Index, relative to a subject experiencing vasomotor symptoms untreated with the dose of gabapentin; and 
 wherein the subject experiences minimal daytime somnolence or reduced daytime somnolence relative to somnolence experienced with an immediate release dose of gabapentin. 
 
     
     
       2. The method of  claim 1 , wherein the subject experiencing vasomotor symptoms is a female experiencing menopause-related hot flashes. 
     
     
       3. The method of  claim 1 , wherein the subject is a post-menopausal female experiencing menopause-related vasomotor symptoms who is at risk of cardiovascular disease. 
     
     
       4. The method of  claim 1 , wherein the subject is a female experiencing menopause-related vasomotor symptoms and contraindicated for hormone-replacement therapy. 
     
     
       5. A dosing regimen for treating a female subject experiencing menopause-related vasomotor symptoms, comprising:
 administering, to a female subject experiencing menopause-related vasomotor symptoms, a first daily dose of gabapentin in a dosage form comprising a hydrophilic polymer, wherein after administration the dosage form swells to a size that is retained in the stomach in a fed mode, the first dose administered for a first time period; and 
 administering to said subject a second daily dose of gabapentin, greater than the first dose of gabapentin, in a dosage form comprising a hydrophilic polymer, wherein after administration the dosage form swells to a size that is retained in a stomach in a fed mode, the second dose administered after the first time period, for a second time period; 
 wherein said first daily dose and said second daily dose comprise a first dosage form administered with a morning meal and at least a second dosage form administered with an evening meal, the first daily dose and the second daily dose providing a total daily dose of about 1800 mg gabapentin; 
 wherein the dosing regimen improves the quality of sleep at night in the subject, as measured by the Pittsburgh Quality Sleep Index, relative to a subject experiencing vasomotor symptoms untreated with the dosage regimen; 
 and wherein the subject experiences minimal daytime somnolence or reduced daytime somnolence relative to somnolence experienced with immediate release dosages of gabapentin. 
 
     
     
       6. The dosing regimen of  claim 5 , whereby the dosing regimen reduces frequency or severity of the menopause-related vasomotor symptoms. 
     
     
       7. The dosing regimen of  claim 5 , wherein the second dose of gabapentin is administered for a third period of time. 
     
     
       8. The dosing regimen of  claim 5 , further comprising administering a third daily dose of gabapentin, less than the second dose of gabapentin, in a dosage form comprising a hydrophilic polymer, wherein after administration the dosage form swells to a size retained in the stomach in the fed mode, the third dose administered after the second time period, for a third time period. 
     
     
       9. The method of  claim 5 , wherein the first daily dose is 600 mg and wherein the second daily dose is 1200 mg. 
     
     
       10. The method of  claim 9 , wherein the first period of time is 2 days and the second period is 3 days. 
     
     
       11. A method of improving quality of sleep at night in a female subject experiencing vasomotor symptoms, comprising:
 administering to a female subject experiencing vasomotor symptoms a dosage form comprised of a dosage unit of about 600 mg of gabapentin, wherein the dosage form is formulated to be of a size that is retained in a stomach in a fed mode, said dosage form administered with a morning meal, and 
 administering to the subject a second dosage unit of about 1200 mg of gabapentin, said dosage unit in one or more dosage forms formulated to be of a size that is retained in a stomach in a fed mode, said dosage form administered with an evening meal, 
 whereby the administering provides an improvement in quality of sleep at night as measured by the Pittsburgh Quality Sleep Index and relative to a female subject experiencing vasomotor symptoms untreated with the dosage form, and whereby the administering either causes minimal daytime somnolence or reduces daytime somnolence as compared to somnolence caused by immediate release gabapentin. 
 
     
     
       12. The method of  claim 1 , wherein the subject is withdrawing from hormone replacement therapy.